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NCT04868877TerminatedPhase 1/2

Phase 1/2 Study Evaluating MCLA-129, a Human Anti-EGFR, Anti-c-MET Bispecific Antibody, in Advanced NSCLC and Other Solid Tumors, Alone and in Combination

Phase 1/2 Dose Escalation and Expansion Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Reason given: The Sponsor terminated the trial early for strategic business reasons. This isn't related to any safety/efficacy/clinical activity/benefit-risk concern with petosemtamab. Ongoing participants will have access to treatment outside of this trial.

Brief summary (registry, in English)

A phase 1/2 open-label multicenter study will be performed with an initial dose escalation part to determine the MTD and/or the RP2D of MCLA-129 in monotherapy or in combination in patients with NSCLC, HNSCC, GC/GEJ, ESCC, or other solid tumors and who are treatment naïve or have progressed after receiving prior therapy for advanced/metastatic disease.

Status (registry)
Terminated
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
194 (actual)
First submitted
9 Apr 2021
Start date
28 Apr 2021
Primary completion date
1 Oct 2026
Lead sponsor
Merus B.V.
NCT number
NCT04868877
EU CT number
2024-514461-19-00

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Central nervous system metastases that are untreated or symptomatic, or require radiation, surgery, or continued steroid therapy (> 10 mg prednisone or equivalent) to control symptoms within 14 days of study entry.
  • Participation in another clinical study or treatment with any investigational drug within 4 weeks prior to study entry.
  • Systemic anticancer therapy or immunotherapy within 4 weeks or 5 half-lives, whichever is shorter, of the first dose of study drug. For cytotoxic agents that have major delayed toxicity (e.g., mitomycin C, nitrosoureas), a washout period of 6 weeks is required.
  • Major surgery or radiotherapy within 3 weeks of the first dose of study drug. Patients who received prior radiotherapy to ≥25% of bone marrow at any time are not eligible.
  • Persistent grade >1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2 NCI-CTCAE v5.0 and hypothyroidism ≤ grade 2 which is stable on hormone replacement are allowed.
  • Previous or concurrent malignancy, excluding non-basal cell carcinomas of skin or carcinoma in situ of the uterine cervix, unless the tumor was treated with curative or palliative intent and in the opinion of the Investigator, with Sponsor agreement, the previous or concurrent malignancy condition does not affect the assessment of safety and efficacy of the study drug.
  • Active Hepatitis B infection without receiving antiviral treatment.

Other illness

  • History of hypersensitivity reaction or any toxicity attributed to human proteins or any of the excipients that warranted permanent cessation of these agents. History of hypersensitivity reaction or any toxicity attributed to chemotherapy and components.
  • History of clinically significant cardiovascular disease
  • Past medical history of ILD or pneumonitis, or any evidence of clinically active ILD or pneumonitis.
  • Current serious illness or medical conditions including, but not limited to uncontrolled active infection, clinically significant pulmonary, metabolic or psychiatric disorders
  • Positive test for Hepatitis C
  • Known history of HIV (HIV 1/2 antibodies). Patients with HIV with undetectable viral load are allowed. In

Other

  • Known leptomeningeal involvement.

Criteria the registry did not label

  • Part One: Patients with NSCLC, GC/GEJ, HNSCC, or ESCC who have failed prior standard first-line treatment. Patients must have progressed on or be intolerant to therapies that are known to provide clinical benefit. There is no limit to the number of prior treatment regimens.
  • Part Two: Patients with NSCLC, HNSCC, other solid tumors and applicable mutations as determined by the investigator.
  • Availability of archival or a fresh tumor tissue sample.
  • Measurable disease as defined by RECIST version 1.1 by radiologic methods.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Life expectancy ≥ 12 weeks, as per Investigator.
  • Adequate organ function (as per protocol)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (51)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Institut Jules BordetAnderlechtBelgiumUnknown status
Antwerp University HospitalEdegemBelgiumUnknown status
Krankenhaus NordwestFrankfurt am MainGermanyUnknown status
Sana Klinikum Offenbach GmbHOffenbachGermanyUnknown status
Hospital de la Santa Creu i Sant PauBarcelonaSpainUnknown status
Hospital Universitario Vall d'HebronBarcelonaSpainUnknown status
IOB Institute of Oncology - Hospital Quironsalud BarcelonaBarcelonaSpainUnknown status
Hospital HM DelfosBarcelonaSpainUnknown status
Centro Integral Oncologico Clara CampalMadridSpainUnknown status
Hospital General Universitario Gregorio MarañónMadridSpainUnknown status
Clinica Universidad de Navarra MadridMadridSpainUnknown status
Hospital Quiron MadridMadridSpainUnknown status
Hospital Universitario Fundación Jiménez DíazMadridSpainUnknown status
Hospital Universitario 12 de OctubreMadridSpainUnknown status
Clínica Universidad de navarraPamplonaSpainUnknown status
Fundacion Instituto Valenciano de Oncologia IvoValenciaSpainUnknown status
Hospital Universitari i Politécnic La FeValenciaSpainUnknown status
Clinique de l'EuropeAmiensFranceUnknown status
CHU Hopitaux de Bordeaux - Hôpital Saint-AndréBordeauxFranceUnknown status
CHU de Lyon - Louis Pradel HospitalBronFranceUnknown status
Centre Hospitalier Intercommunal de CréteilCréteilFranceUnknown status
Hôpital Albert CalmetteLilleFranceUnknown status
L'Institut Paoli - CalmettesMarseilleFranceUnknown status
CHU de Nantes - Hopital Nord LaennecNantesFranceUnknown status
Marie WislezParisFranceUnknown status
Hôpital Européen Georges Pompidou (HEGP)ParisFranceUnknown status
Hôpital Bichat - Claude-BernardParisFranceUnknown status
CHU de PoitiersPoitiersFranceUnknown status
Hôpital d'Instruction des Armées BéginSaint-MandéFranceUnknown status
Azienda Ospedaliero Universitaria Di Bologna Policlinico S. Orsola MalpighiBolognaItalyUnknown status
Asst Degli Spedali Civili Di BresciaBresciaItalyUnknown status
ASST Grande Ospedale Metropolitano NiguardaMilanItalyUnknown status
Fondazione IRCCS - Istituto Nazionale dei TumoriMilanItalyUnknown status
Azienda Ospedaliero-Universitaria San Luigi GonzagaOrbassanoItalyUnknown status
Istituto Nazionale dei Tumori Regina ElenaRomaItalyUnknown status
Azienda Ospedaliera Universitaria San Giovanni di Dio e Ruggi d'AragonaSalernoItalyUnknown status
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo TrentoVeronaItalyUnknown status
Gachon University Gil HospitalIncheonSouth KoreaUnknown status
Severance Hospital Yonsei Cancer CenterSeoulSouth KoreaUnknown status
Samsung Medical CenterSeoulSouth KoreaUnknown status
The Catholic University of Korea, Seoul ST. Mary's HospitalSeoulSouth KoreaUnknown status
Seoul National University HospitalSeoulSouth KoreaUnknown status
The Catholic University of Korea, St. Vincent's HospitalSuwon, Gyeonggi-doSouth KoreaUnknown status
Netherlands Cancer InstituteAmsterdamNetherlandsUnknown status
University Medical Center GroningenGroningenNetherlandsUnknown status
Erasmus Medical CenterRotterdamNetherlandsUnknown status
National Cancer Centre of SingaporeSingaporeSingaporeUnknown status
NEXT Oncology- VirginiaFairfaxUnited StatesUnknown status
Sarah Cannon Research InstituteNashvilleUnited StatesUnknown status
University of California IrvineOrangeUnited StatesUnknown status
START Mountain RegionWest Valley CityUnited StatesUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.